KH
Validation Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
6 months ago
- PFMEA
- Technical Writing
6 months ago
Not enough detail in this posting to match
- We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments.
- Candidates must have strong hands-on expertise in IQ/OQ/PQ protocol development and execution for both new and legacy manufacturing processes and equipment, as well as Test Method Validation (TMV) and Computerized System Validation (CSV) in accordance with GAMP 5.
- A solid working knowledge of regulatory frameworks is essential — specifically ISO 13485, ISO 14971, EU IVDR 2017/746, and FDA 21 CFR 820 — along with demonstrated ability to develop and maintain Master Validation Plans, define CTQ-based acceptance criteria, and establish traceability across risk controls, process parameters, and validation outputs.
- Experience with PFMEA and change control impact assessments is also expected.
- On the analytical side, candidates should be proficient in statistical methods used in validation, including Measurement System Analysis (MSA), process capability analysis, and sampling plan design.
- Familiarity with CLSI guidelines and ISO 15189 for analytical/diagnostic method validation is a plus given the IVD product focus.
- Strong technical writing skills are a must — this person will be authoring protocols, deviation reports, and validation summaries that must hold up to regulatory scrutiny.
- Cross-functional collaboration with Quality, Manufacturing Engineering, R&D, QC, Regulatory Affairs, and IT is a core part of the day-to-day, so candidates should be comfortable driving validation workstreams independently across multiple concurrent projects.
Validation Engineer · Katalyst Healthcares & Life Sciences